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Process Manager
2 weeks ago
About the Company: We are seeking an experienced Process Manager with a minimum of 7 years in operations or manufacturing, including hands-on experience managing sterilization processes (e.g., ETO, Gamma, Steam, H2O2). The ideal candidate will be responsible for optimizing, validating, and ensuring the compliance of sterilization operations within our facility. This role will lead process improvement initiatives, support new product integration, and maintain compliance with global regulatory standards (e.g., FDA, ISO 11135/11137/17665).
About the Role: The Process Manager will oversee and manage all aspects of the sterilization process, ensuring adherence to safety, quality, and regulatory standards.
Responsibilities:
- Oversee and manage all aspects of the sterilization process, ensuring adherence to safety, quality, and regulatory standards.
- Lead the development, validation, and continuous improvement of sterilization processes including ETO, Gamma, Steam, or Hydrogen Peroxide.
- Collaborate with cross-functional teams (QA, R&D, Production, Regulatory) for successful technology transfers, process validations (IQ/OQ/PQ), and CAPA implementation.
- Monitor and analyze process metrics, identifying trends and implementing corrective actions to improve efficiency, yield, and compliance.
- Ensure regulatory compliance with applicable standards (ISO 13485, ISO 11135/11137/17665, FDA CFR 21, EU MDR).
- Manage and maintain documentation related to process validations, deviations, NCRs, and change controls.
- Train and mentor junior engineers and technicians on sterilization and related manufacturing processes.
- Support audits and inspections by regulatory bodies and customers.
Qualifications: Minimum of 7 years in operations or manufacturing, including hands-on experience managing sterilization processes.
Required Skills: Experience with sterilization processes (e.g., ETO, Gamma, Steam, H2O2), strong understanding of regulatory compliance, and ability to lead process improvement initiatives.
